The Effects of the Melillo Method® on Biopsychosocial Outcomes in School-Age Children

NCT07779889 | Recruiting

• 1 other identifier: TP071326
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study will test whether a school-based neurodevelopmental brain-training program, called the Melillo Method®, is feasible to deliver and study in elementary and middle school students who are struggling with behavior and learning. The study will enroll about 34 children ages 8 and older at two schools in Illinois. Children will be identified by teachers and school staff as needing extra support, and families will complete a brief questionnaire to confirm eligibility. Children who qualify will be randomly assigned to start the program right away (24 weeks of sessions) or after a delay (12 weeks of sessions, starting partway through the study). This "delayed-start" design lets every enrolled child eventually receive the program while still allowing researchers to compare outcomes between children who started earlier versus later. The program combines sensory stimulation (lights, gentle vibration, scent), rhythm-based exercises, primitive reflex integration activities, and balance/coordination training, delivered by a trained clinician in small groups of two. Sessions occur three times per week for about 20 minutes each. Researchers will measure whether the study procedures are practical and acceptable. For example, how many eligible families enroll, how well families and teachers complete follow-up questionnaires, how well students tolerate the assessments, and how consistently families attend sessions. As a secondary goal, the study will explore whether children show changes in thinking skills, fine motor coordination, and emotional/behavioral functioning, measured using standardized tools (the NIH Toolbox and the Strengths and Difficulties Questionnaire) completed by the children, their parents, and their teachers. This is a feasibility study. It is not intended to prove that the program works, but rather to determine whether a larger, more rigorous trial is realistic and well-designed.

Conditions

Social Behavior Disorders; Neurodevelopmental Disorders

Keywords

Pilot Projects; Pediatrics; Melillo Method

Outcome Measures

Primary Outcomes (7)

• Proportion of consenting parents

  Number of parents who consent, divided by the total number of eligible students identified via the online screen. This assesses 'Consent rate'

  Through study completion (up to 10 months)

• Proportion Strength and Difficulties Questionnaire - Teacher version (SDQ-T) completed

  The number of SDQ-T surveys completed, divided by the total number of SDQ-T surveys sent. This assesses teacher-level 'Response'

  Through study completion (up to 10 months)

• Proportion Strength and Difficulties Questionnaire - Parent version (SDQ-P) completed

  The number of SDQ-T surveys completed, divided by the total number of SDQ-T surveys sent. This assesses parent-level 'Response'

  Through study completion (up to 10 months)

• Proportion of completed assessment batteries

  The number of completed assessment batteries, divided by the total number of attempted assessment batteries. This assesses 'Tolerability'

  Through study completion (up to 10 months)

• Proportion of students adhering to the care plan

  The number of enrolled students attending at least 90% of their scheduled therapy sessions, divided by the total number of students attending therapy (excludes sessions scheduled after withdrawal). This assesses 'Adherence'

  Through study completion (up to 10 months)

• Proportion of students retained in the immediate-start arm

  The number of students allocated to the immediate-start arm attending the end-trial assessment session, divided by the total number of students allocated to the immediate-start arm. This assesses experimental arm 'Retention'

  Through study completion (up to 10 months)

• Proportion of students retained in the delayed-start arm.

  Number of students in the delayed-start arm attending the end-trial assessment session divided by the total number of students allocated to the delayed-start arm. This assesses control-arm 'Retention'

  Through study completion (up to 10 months)

Secondary Outcomes (5)

• Change difference in NIH Toolbox (v3) Cognition Battery Composites

  Through study completion (up to 10 months)

• Change difference in NIH Toolbox (v3) Emotion Battery Composites

  Through study completion (up to 10 months)

• Change difference in the NIH Toolbox (v3) 9-hold Pegboard Dexterity Test

  Through study completion (up to 10 months)

• Change difference in the Strengths & Difficulties Questionnaire - Parent (SDQ-P)

  Through study completion (up to 10 months)

• Change difference in the Strengths & Difficulties Questionnaire - Teacher (SDQ-T)

  Through study completion (up to 10 months)

Study Arms (2)

Immediate-start

EXPERIMENTAL

Participants in this arm will receive \~24 weeks (3x week) of Melillo Method therapy

Procedure: Melillo Method

Delayed-start

ACTIVE COMPARATOR

Participants in this arm will be allocated to a waitlist followed by \~12 weeks (3x week) of Melillo Method therapy

Procedure: Melillo Method

Interventions

Melillo Method PROCEDURE

The intervention is delivered by a Melillo Method-certified clinician and a trained assistant in dyadic (n=2) small-group format, three sessions weekly. This group size is intended to preserve a high clinician-to-student ratio for individualized manual therapy while allowing structured peer-to-peer engagement during cooperative timing tasks. Each intervention block begins and concludes with a standardized neurodevelopmental assessment (primitive reflex grading, postural and oculomotor evaluation, Interactive Metronome baseline timing metrics) to characterize functional status independent of the ongoing outcome battery. Participants are assigned to a right- or left-hemisphere-targeted stimulation protocol based on clinical synthesis of neurobehavioral history and observed asymmetry patterns, determining the laterality of sensory stimulation (visual, tactile-vibratory, olfactory, and auditory) and the directionality of oculomotor an

Also known as: Functional Neurology

Delayed-start; Immediate-start

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• + years old
• Attends Roodhouse Elementary or North Greene Jr. High School
• Screening SDQ-P Total Difficulties Score ≥17 and Total Impact Score ≥2

You may not qualify if:

• History of Epilepsy
• Diagnosis of Oppositional Defiance Disorder (ODD) or Conduct Disorder (CD)
• Impairments that preclude standardized administration of the assessments and/or therapy (e.g., uncorrected visual or hearing loss, paralysis of the arms or legs)

Sponsors & Collaborators

• Life University: lead

Study Sites (1)

North Greene School District

Roodhouse, Illinois, 62082, United States

RECRUITING

MeSH Terms

Conditions

Neurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Tyson Perez

  Life University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Associate Vice President of Research

CONTACT

678-331-4527; research.studies@life.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Data analyst
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 13, 2026
• First Posted: August 21, 2026
• Study Start: September 14, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: September 22, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: (start date): within 1 year of study completion. (end date): indefinitely
• Access Criteria: IPD, metadata \& analytic code necessary to reproduce results will be made publicly accessible via a data repository

Locations

US (1)